Senior Manager Biostatistics (Finance)

Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Primary Function of Position

As a Senior Manager of Biostats in the Clinical Affairs department, this role is primary responsible for leading with statistical design and analysis strategy for clinical investigations support of regulatory submissions, evidence generation and scientific publication efforts. This position will partner with key internal and external stakeholders to design, analyze, and interpret clinical investigations in support of Intuitive's clinical development.

As a people leader, this role is also responsible for developing and managing the biostats team to interface and support multiple clinical investigations and other scientific evidence generation projects while following all applicable guidelines and regulations. Will manage and support all clinical affairs operations regarding all biostatistical needs along with some statistical support for other groups such as engineering or other research projects.

Essential Job Duties

(Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)

• Play a strategic role in the development of Intuitive sponsored clinical investigations globally
• Responsible for providing statistical support for clinical investigations in study design, analysis, interpretation and publication of clinical investigations
• Responsible for managing the development of Statistical Analysis Plan, designing shells for tables, listings and figures and developing programming specifications for statistical analysis for clinical investigations.
• Responsible for addressing regulatory authority questions related to statistical design and analysis for all pre-approval clinical investigations and post approval studies or post-market clinical follow up studies which are overseen by regulatory authorities
• Responsible for conducting data analysis to support the development of clinical study report, clinical evaluation report, conference or journal publications, and other regulatory submission as needed
• Represent the Biostatistics function within the cross-functional study team, collaborate with other team members for the development of Clinical Investigational Plan, Clinical Study Report, Case Report Form and other key study documents

• Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US FDA regulations and guidelines, ISO14155) and responsible for ongoing review of departmental procedures and process improvement initiatives
• Develop long range plans regarding development of biostats to meet current and future needs

Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)

• Work closely with Data management to define edit specifications and critical variable lists, support data cleaning activities to ensure collection of high-quality data; handles database lock and unblinding process per study requirements
• Work closely with internal/external authors to assist development of manuscript, abstract/presentation or poster, and provide statistical support throughout the publication process
• Act as a key strategic partner to develop evidence generation strategy across surgical specialties and product platforms
• Lead additional research projects to generate clinical evidence, such as data analysis of large clinical databases, systematic literature reviews and meta-analysis, etc.
• Stay abreast of latest industry and academic developments in Statistics and modeling techniques and apply adapting methodology to solve unique or challenging study design and statistical analysis issues
• Provide functional manager leadership to direct reports and provide ongoing guidance for the assigned team members in their internal/external communication and support direct reports in consistently achieving their goals and objectives
• Effectively distills complexity and provides clear and actionable direction and information, help team prioritize, solve complex problems that enable the team to make significant
• A minimum of 3-5 years of people management experience with direct reports; experience building a biostats team over time is desirable
• Proficient in R and/or SAS programming and/or a suitable statistical programming environment
• Strong knowledge of 21 CFR part 812, Good Clinical Practice, ISO14155 and other regulations/guidelines on clinical research
• Excellent verbal/written communication, presentation, teamwork and interpersonal skills; capability to build strong cross-functional collaboration both internally and externally

Qualifications
Required Education and Training

(As applicable - Specific education and training that an individual must possess in order to successfully perform in job)

• Minimum of 10 years of biostats clinical research experience working in a medical device or related industry.
• Advanced degree in Biostatistics or Statistics (Masters or Ph. D) with sound knowledge of theoretical and applied statistics

Working Conditions

• None

Preferred Skills and Experience

• Proven track record of success in designing a wide range of clinical investigations using various statistical methodology; experience in adaptive design (e.g., sample size re-estimation, Bayesian adaptive design) and using historical control is preferred
• Clinically savvy and be able to bridge analytics to clinical interpretation and explain complex mathematical/statistical problems to team members and senior leadership
• Experience with analyses of a large dataset (administrative or commercial data sets) is desirable

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Base Salary Range Region 1: $184,400 USD - $276,600 USD
Base Salary Range Region 2: $156,700 USD - $235,100 USD
Shift: Day
Workplace Type: Purposeful Onsite - This job requires being onsite for leader-defined events and activities which could be monthly/annually. Onsite frequency may increase based on business need.